ZebraRecalls & reported problems across all models

We found 8 models of Zebra by Q'Apel Medical LLC in the FDA's device registry (GUDID). Together they are named in 24 adverse event reports in the FDA's MAUDE database, received between Mar 4, 2025 and Aug 26, 2026 — classified as 2 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Fracture” (13 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Zebra problems

Zebra models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Zebra AC7087-095-20-S

  Catheter, Percutaneous
  8 reports
• Zebra AC7087-095-20-B

  Catheter, Percutaneous
  6 reports
• Zebra AC7087-105-20-S

  Catheter, Percutaneous
  3 reports
• Zebra AC6074-095-30

  Catheter, Percutaneous
  2 reports
• Zebra AC6074-095-20

  Catheter, Percutaneous
  2 reports
• Zebra AC7087-105-20-B

  Catheter, Percutaneous
  1 report
• Zebra AC6074-105

  Catheter, Percutaneous
  1 report
• Zebra AC7087-095

  Catheter, Percutaneous
  1 report

Recent Zebra adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50464562 ↗
• MalfunctionAug 8, 2026Break; Failure to Advance; Material Deformation

  On July 13, 2026, Q'Apel Medical became aware of a reported device malfunction involving a Q'Apel Medical Zebra Neurovascular Access Catheter, 6F x 105 cm (REF AC6074-105, Lot FG260401B-01), that occurred on (b)(6) 2026 during a left middle meningeal artery (MMA) embolization procedure at (b)(6) Hospital. Per the site report, the procedure was converted from a right radial to a femoral approach due to tortuous anatomy. While advancing a microcatheter through the subject catheter, resistance was encountered. The physician removed the subject catheter and the catheter was noted to have separated into two pieces during this removal. No additional retrieval device or intervention was required; both separated components were removed from the patient without difficulty. A replacement catheter was used and the procedure was completed without further complication. The site reported no patient injury or adverse clinical outcome; the only reported impact was a prolonged procedure.Returned product analysis identified two separated catheter shaft segments: a proximal segment measuring approximately 31 cm and a distal segment measuring approximately 80.5 cm (combined approximately 111.5 cm, app

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50187258 ↗
• MalfunctionAug 6, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50150675 ↗
• MalfunctionMay 28, 2026Break

  ON (B)(6) 2026, DURING A NEUROVASCULAR PROCEDURE PERFORMED VIA FEMORAL ACCESS, A ZEBRA 7F 95 CM CATHETER WAS UTILIZED WITH A CORDIS 5F SIM 125 CM DIAGNOSTIC CATHETER WHILE NAVIGATING TORTUOUS ILIAC ANATOMY AND TRACKING ACROSS THE AORTIC ARCH. DURING USE, RESISTANCE WAS REPORTEDLY ENCOUNTERED AND SALINE LEAKAGE WAS OBSERVED FROM A KINKED REGION OF THE ZEBRA CATHETER APPROXIMATELY 1 INCH DISTAL TO THE STRAIN RELIEF SEGMENT. THE SIM CATHETER WAS SUBSEQUENTLY IDENTIFIED TO BE FRACTURED WITHIN THE ZEBRA CATHETER. THE PROXIMAL PORTION OF THE SIM CATHETER WAS REMOVED, AFTER WHICH THE ZEBRA CATHETER WAS PARTIALLY WITHDRAWN AND CUT TO EXPOSE THE RETAINED SIM CATHETER SEGMENT. THE ZEBRA AND RETAINED SIM CATHETER SEGMENT WERE THEN CLAMPED TOGETHER AND REMOVED SIMULTANEOUSLY FROM THE PATIENT. THE SEPARATED SIM CATHETER SEGMENT REMAINED ACCESSIBLE OUTSIDE THE PATIENT VASCULATURE; REMOVAL WAS COMPLETED WITHOUT INVASIVE RETRIEVAL OR SURGICAL INTERVENTION, NO RETAINED FRAGMENTS REMAINED IN THE PATIENT, AND NO PATIENT INJURY OR MEDICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT WAS REPORTED. THE PHYSICIAN SUBSEQUENTLY CONVERTED TO ANOTHER CATHETER, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25319738 ↗
• InjuryMay 26, 2026Break

  DURING A NEUROVASCULAR PROCEDURE PERFORMED ON (B)(6) 2026 VIA RIGHT RADIAL ACCESS, A ZEBRA 7F 95 CM SIM2 CATHETER WAS REPORTEDLY ADVANCED THROUGH TORTUOUS ANATOMY INVOLVING A SHARP INNOMINATE ARTERY TAKEOFF. RESISTANCE WAS REPORTEDLY ENCOUNTERED DURING ADVANCEMENT AND WITHDRAWAL. DURING REMOVAL, A KINK WAS REPORTEDLY OBSERVED ALONG THE DISTAL SHAFT OF THE CATHETER. WHILE WITHDRAWING THE DEVICE, THE CATHETER REPORTEDLY SEPARATED NEAR THE PROXIMAL SHAFT REGION, RESULTING IN SEPARATION INTO TWO PIECES. THE DISTAL CATHETER SEGMENT REPORTEDLY REMAINED PARTIALLY WITHIN THE PATIENT VASCULATURE AND WAS PHYSICIAN INTERVENTION WAS REQUIRED TO REMOVE THE RETAINED CATHETER SEGMENT FROM THE PATIENT VASCULATURE. THE PHYSICIAN REPORTEDLY RE-ACCESSED THE PATIENT AND COMPLETED THE PROCEDURE SUCCESSFULLY USING A DIFFERENT CATHETER. THE PATIENT OUTCOME WAS REPORTED STABLE POST-PROCEDURE. THE RETURNED DEVICE WAS RECEIVED FOR EVALUATION IN TWO SEPARATED PIECES. VISUAL EXAMINATION CONFIRMED CATHETER SEPARATION APPROXIMATELY 2.5 CM DISTAL TO THE STRAIN RELIEF. THE RETURNED CATHETER LENGTH WAS CONSISTENT WITH MANUFACTURED SPECIFICATION AND NO SIGNIFICANT ELONGATION WAS IDENTIFIED. ADDITIONAL SHAFT BENDS/D

  Patient problems: Insufficient Information

  MAUDE report 25280527 ↗
• InjuryMay 21, 2026Break

  DURING AN MMA EMBOLIZATION PROCEDURE PERFORMED VIA FEMORAL ACCESS ON (B)(6) 2026, RESISTANCE WAS REPORTEDLY ENCOUNTERED BY THE PHYSICIAN DURING WITHDRAWAL OF A ZEBRA 6F 95 CM CATHETER WITHIN TORTUOUS ILIAC ANATOMY. THE PHYSICIAN REPORTED ASSOCIATED VESSEL SPASM, AFTER WHICH THE CATHETER REPORTEDLY KINKED, TWISTED, AND SEPARATED DURING REMOVAL ATTEMPTS. THE SEPARATED CATHETER SEGMENTS WERE REPORTEDLY RETRIEVED USING A SNARE, AND NO FRAGMENTS WERE REPORTED TO REMAIN IN THE PATIENT. THE PATIENT WAS REPORTED TO BE STABLE FOLLOWING RETRIEVAL OF THE CATHETER SEGMENTS. THE PRODUCT WAS RETURNED IN FOUR SHAFT SEGMENTS. EVALUATION IDENTIFIED MULTIPLE FRACTURE/SEPARATION LOCATIONS. THE COMBINED SEGMENT LENGTHS WERE CONSISTENT WITH THE MANUFACTURED DEVICE LENGTH SPECIFICATION, AND NO SIGNIFICANT ELONGATION WAS IDENTIFIED. VISUAL AND MICROSCOPIC EVALUATION IDENTIFIED TWISTING, FLATTENING, PINCHING, AND LOCALIZED COMPRESSION DAMAGE ACROSS MULTIPLE REGIONS OF THE CATHETER. THE FRACTURE MORPHOLOGY APPEARED TORN AND IRREGULAR, CONSISTENT WITH MECHANICAL STRESS DURING DEVICE REMOVAL AND RETRIEVAL. FEED GAP SPACING AND REINFORCEMENT PATTERN WERE OBSERVED TO BE UNIFORM THROUGHOUT THE EVALUATED REGIONS

  Patient problems: Insufficient Information

  MAUDE report 25239303 ↗
• MalfunctionMay 15, 2026Break

  DURING A NEUROVASCULAR PROCEDURE, A ZEBRA 6 FR CATHETER (FG 01194-01, LOT FG250917C-02) WITH A SIM2 DISTAL CONFIGURATION WAS REPORTEDLY USED FOR VASCULAR ACCESS. DURING THE PROCEDURE, THE DISTAL SIM2 TIP SEGMENT REPORTEDLY SEPARATED FROM THE CATHETER. LIMITED PROCEDURAL DETAILS WERE AVAILABLE AT THE TIME OF MDR SUBMISSION DESPITE FOLLOW-UP ATTEMPTS WITH THE SALES REPRESENTATIVE AND PHYSICIAN. NO ADDITIONAL INFORMATION REGARDING THE EXACT PROCEDURAL SEQUENCE, RESISTANCE ENCOUNTERED, PATIENT OUTCOME, OR RETRIEVAL DETAILS WAS AVAILABLE. ONLY THE SEPARATED SIM2 DISTAL TIP SEGMENT WAS RETURNED FOR EVALUATION. RETURNED PRODUCT ANALYSIS IDENTIFIED COMPLETE SEPARATION OF THE DISTAL TIP SEGMENT WITH MEASURED ELONGATION OF APPROXIMATELY 4.5 CM RELATIVE TO NOMINAL MANUFACTURED LENGTH, CONSISTENT WITH SIGNIFICANT TENSILE LOADING PRIOR TO SEPARATION. NO EVIDENCE OF MANUFACTURING OR MATERIAL NONCONFORMANCE WAS IDENTIFIED IN THE RETURNED SEGMENT EVALUATION. THE OBSERVED DAMAGE MORPHOLOGY WAS CONSISTENT WITH MECHANICAL OVERSTRESS ENCOUNTERED DURING CLINICAL USE. AT THE TIME OF THIS REPORT, NO ADDITIONAL PATIENT INJURY INFORMATION HAD BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 25191804 ↗
• MalfunctionMay 7, 2026Fracture

  THE CUSTOMER REPORTED THAT DURING PREPARATION FOR A NEUROVASCULAR PROCEDURE ON (B)(6) 2026, A ZEBRA 7F 95 CM SIM2 CATHETER WAS REMOVED FROM THE PRODUCT PACKAGING AND PREPARED FOR USE. THE SCRUB TECHNICIAN REPORTEDLY FLUSHED THE CATHETER WHILE IT REMAINED WITHIN THE PROTECTIVE TUBING, AND RESISTANCE WAS NOTED DURING FLUSHING. AFTER REMOVAL FROM THE PROTECTIVE TUBING, A DISTAL SHAFT KINK WAS REPORTEDLY OBSERVED. THE CUSTOMER REPORTED THAT THE DEVICE WAS NOT USED FOR PATIENT TREATMENT, AND AN ALTERNATE DEVICE WAS UTILIZED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITHOUT REPORTED PATIENT INJURY OR ADVERSE CLINICAL OUTCOME. THE DEVICE WAS RETURNED TO Q'APEL MEDICAL ON 4/20/2026 AND UNDERWENT PRODUCT EVALUATION ON 4/23/2026. THE RETURNED PRODUCT EVALUATION IDENTIFIED FINDINGS THAT ARE INCONSISTENT WITH THE REPORTED EVENT DESCRIPTION. VISUAL INSPECTION IDENTIFIED A SEVERE PROXIMAL SHAFT KINK/FRACTURE APPROXIMATELY 10-11 CM FROM THE HUB/STRAIN RELIEF. WHEN FLUSHING THE CENTRAL LUMEN, LEAKAGE FROM THE FRACTURED REGION CONFIRMED A LUMEN BREACH. ADDITIONALLY, BLOOD WAS OBSERVED EXITING THE DISTAL TIP OF THE CENTRAL LUMEN DURING FLUSHING, SUGGESTING THE DEVICE MAY HAVE BEEN EXPOSED TO BLOOD OR I

  Patient problems: Insufficient Information

  MAUDE report 25117588 ↗
• MalfunctionMay 6, 2026Fracture

  DURING A NEUROVASCULAR PROCEDURE ON (B)(6) 2026, PERFORMED VIA FEMORAL ACCESS USING A 7FR SHEATH, A ZEBRA 7FR 105 CM SIM2 CATHETER WAS USED IN CONJUNCTION WITH A WINGSPAN SYSTEM. THE CATHETER WAS INSPECTED PRIOR TO USE, AND NO DEFECTS WERE OBSERVED. THE CATHETER WAS ADVANCED TO A HIGH CERVICAL POSITION; HOWEVER, DIFFICULTY WAS ENCOUNTERED WHILE ADVANCING A MICROCATHETER AND MICROWIRE TO THE MIDDLE CEREBRAL ARTERY (MCA). DURING THE PROCEDURE, A KINK WAS OBSERVED FLUOROSCOPICALLY IN THE AORTIC ARCH REGION. A SECOND KINK WAS SUBSEQUENTLY VISUALLY IDENTIFIED IN A SEGMENT OF THE CATHETER EXTERNAL TO THE PATIENT. SALINE LEAKAGE WAS OBSERVED AT THE LOCATION OF THE EXTERNAL KINK. THE CATHETER WAS FLUSHED FOLLOWING REMOVAL FROM THE PATIENT, CONFIRMING A LUMEN BREACH/FRACTURE CORRESPONDING TO THIS REGION. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER ZEBRA CATHETER FROM THE SAME LOT, WHICH WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUE. NO PATIENT INJURY OR ADVERSE CLINICAL OUTCOME WAS REPORTED. RETURNED PRODUCT EVALUATION CONFIRMED A LOCALIZED LUMEN BREACH/FRACTURE ASSOCIATED WITH THE EXTERNALLY KINKED REGION. MICROSCOPIC EVALUATION OF THE FRACTURE REGION DID NOT I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25107623 ↗
• MalfunctionMar 24, 2026Fracture

  ON (B)(6), 2026, Q'APEL MEDICAL BECAME AWARE OF A REPORTED ZEBRA 6F 95 CM BERNSTEIN CATHETER FRACTURE THAT OCCURRED DURING A PIPELINE EMBOLIZATION PROCEDURE. THE DEVICE WAS INTRODUCED VIA A MERIT 22 CM 7F SHEATH AND ADVANCED TO THE HIGH PETROUS CAROTID THROUGH TORTUOUS ANATOMY, INCLUDING A 360-DEGREE CERVICAL CAROTID LOOP. THE CATHETER WAS INSPECTED PRIOR TO USE AND NO DEFECTS WERE OBSERVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTED PATIENT INJURY. DURING WITHDRAWAL OF THE ZEBRA CATHETER THROUGH THE STATIONARY SHEATH, WHICH WAS NOT RETRACTED, RESISTANCE WAS ENCOUNTERED IN THE CERVICAL CAROTID REGION. THE PHYSICIAN REPORTED THAT THE CATHETER WAS NOT ROTATED, NO VASOSPASM OCCURRED, AND NO EXCESSIVE FORWARD PRESSURE WAS APPLIED. THE PHYSICIAN INDICATED THE MALFUNCTION LIKELY OCCURRED DURING WITHDRAWAL. FOLLOWING REMOVAL, A KINK WAS OBSERVED AND FLUID LEAKAGE WAS NOTED AT THE KINK SITE. NO MULTIPLE REPOSITIONING ATTEMPTS WERE REQUIRED, AND NO TIP MODIFICATION WAS PERFORMED. THE DEVICE WAS REMOVED FROM THE PATIENT AND NO ADDITIONAL INTERVENTION WAS REQUIRED. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION ON (B)(6), 2026. RETURNED PRODUCT ANALYSIS CONFIRMED A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24676979 ↗
• MalfunctionMar 2, 2026Break

  DURING A NEUROVASCULAR PROCEDURE PERFORMED BY DR. (B)(6), A ZEBRA WAS USED VIA A 7F SLENDER INTRODUCER SHEATH. AFTER SELECTION OF THE RIGHT INTERNAL CAROTID ARTERY AND REMOVAL OF A 5F SIM2 COOK CATHETER, THE ADJUNCTIVE DEVICES (VECTA 46, V17, AND SYNCHRO) WERE ADVANCED THROUGH THE ZEBRA CATHETER, A FRACTURE WAS OBSERVED AT THE DISTAL SEGMENT. A 0.035" GLIDEWIRE WOULD NOT PASS THROUGH THE FRACTURED REGION. THE ZEBRA CATHETER WAS GENTLY WITHDRAWN FROM THE PATIENT; THE SHAFT REMAINED ATTACHED DURING REMOVAL, BUT COMPLETELY SEPARATED AFTER EXITING THE SHEATH. AT THE TIME OF THIS REPORT, Q'APEL MEDICAL HAS NOT RECEIVED THE DEVICE FOR EVALUATION.

  Patient problems: Insufficient Information

  MAUDE report 24480527 ↗
• MalfunctionMar 2, 2026Fracture

  ON (B)(6) 2026, DURING A LEFT CAROTID ARTERY STENTING (CAS) PROCEDURE PERFORMED VIA RIGHT RADIAL ACCESS, A ZEBRA CATHETER WAS POSITIONED IN THE PROXIMAL COMMON CAROTID ARTERY. DUE TO NEAR-COMPLETE OCCLUSION OF THE LEFT INTERNAL CAROTID ARTERY, MULTIPLE ATTEMPTS WERE MADE TO ADVANCE ANCILLARY DEVICES. DURING ONE ATTEMPT, CONTRAST LEAKAGE WAS VISUALIZED FLUOROSCOPICALLY FROM THE CATHETER AT THE CURVE OF THE BRACHIOCEPHALIC ARTERY. THE CATHETER REMAINED IN POSITION TO PROVIDE SUPPORT AND WAS WITHDRAWN FOLLOWING COMPLETION OF THE PROCEDURE. NO FRAGMENTS WERE RETAINED, AND NO PATIENT INJURY OR ADVERSE CLINICAL OUTCOME WAS REPORTED. EVALUATION OF THE RETURNED DEVICE CONFIRMED A CATHETER SHAFT BREACH APPROXIMATELY 19 CM FROM THE DISTAL TIP (77 CM FROM THE HUB), AS EVIDENCED BY FLUID LEAKAGE DURING FLUSHING. THE DEVICE WAS RETURNED IN ONE PIECE. MICROSCOPIC AND VISUAL INSPECTION OF THE FRACTURE REGION DEMONSTRATED UNIFORM REINFORCEMENT CUT SPACING WITH NO ABNORMAL PITCH VARIATION OR REINFORCEMENT STRUT FRACTURE. THE DAMAGE PATTERN WAS CHARACTERIZED BY LOCALIZED MECHANICAL STRAIN BETWEEN REINFORCEMENT CUTS, RESULTING IN SHEARING OF THE OUTER POLYMER JACKET AND A SLIGHT OPENING OF THE INTERN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24480485 ↗
• MalfunctionFeb 25, 2026Fracture

  ON JANUARY 27, 2026, Q'APEL MEDICAL BECAME AWARE OF AN EVENT INVOLVING A ZEBRA 7F 95 CM BERNSTEIN CATHETER DURING AN ANEURYSM EMBOLIZATION PROCEDURE PERFORMED VIA RADIAL ACCESS. AFTER SELECTING THE RIGHT INTERNAL CAROTID ARTERY AND REMOVING A 5F SIM2 COOK CATHETER, RESISTANCE WAS ENCOUNTERED WHILE ADVANCING A VECTA 46, V17, AND SYNCHRO THROUGH THE ZEBRA CATHETER. A 0.035" GLIDEWIRE WOULD NOT PASS. A FRACTURE WAS OBSERVED IN VIVO AT APPROXIMATELY THE DISTAL ONE-THIRD OF THE CATHETER. THE DEVICE WAS GENTLY WITHDRAWN AND REMAINED INTACT DURING REMOVAL; HOWEVER, COMPLETE SEPARATION OCCURRED AFTER EXITING THE SHEATH. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE CATHETER. NO DEVICE FRAGMENTS WERE RETAINED IN THE PATIENT. NO VESSEL INJURY, DISSECTION, PERFORATION, EMBOLIZATION, VASOSPASM, ADDITIONAL INTERVENTION, OR ADVERSE CLINICAL OUTCOME WAS REPORTED. THE PATIENT OUTCOME WAS STABLE. RETURNED PRODUCT EVALUATION CONFIRMED A CATHETER SHAFT SEPARATION LOCATED APPROXIMATELY 19-20 CM FROM THE DISTAL TIP AT THE JACKET TRANSITION REGION. MICROSCOPIC EXAMINATION DEMONSTRATED SEPARATION OF THE LASER CUT TUBE (LCT) WITH INWARD COLLAPSE TOWARD THE LUMEN AND ASSOCIATED POLYMER DISRUPTION. THE FRA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24449289 ↗
• MalfunctionFeb 23, 2026Fracture

  ON JANUARY 23, 2026, Q'APEL MEDICAL BECAME AWARE OF AN EVENT INVOLVING A 7F 95 CM SIM 2 ZEBRA CATHETER DURING A MECHANICAL THROMBECTOMY PROCEDURE PERFORMED VIA RIGHT RADIAL ACCESS. THE CATHETER WAS PREPARED AND FLUSHED PER THE INSTRUCTIONS FOR USE AND ADVANCED TO THE HIGH CERVICAL INTERNAL CAROTID ARTERY. TWO THROMBECTOMY PASSES WERE PERFORMED USING ADJUNCTIVE DEVICES. TICI 3 REVASCULARIZATION WAS ACHIEVED. UPON WITHDRAWAL OF THE ZEBRA CATHETER THROUGH THE SHEATH, A PARTIAL SHAFT FRACTURE WAS OBSERVED. NO RESISTANCE OR UNUSUAL MANIPULATION WAS REPORTED DURING USE OR REMOVAL. NO DEVICE FRAGMENTS WERE RETAINED IN THE PATIENT, AND NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT OUTCOME WAS REPORTED AS STABLE. RETURNED PRODUCT EVALUATION CONFIRMED A CATHETER SHAFT BREACH APPROXIMATELY 19 CM FROM THE DISTAL TIP, CHARACTERIZED BY POLYMER JACKET AND LINER SEPARATION. MICROSCOPIC AND VISUAL INSPECTION OF THE DAMAGED REGION IDENTIFIED NO ABNORMAL LASER-CUT TUBE (LCT) STRUT PATTERN, PITCH VARIATION, OR GEOMETRIC IRREGULARITY. THE DISTAL TIP SHOWED NO ABNORMALITIES. NO EVIDENCE OF MANUFACTURING NONCONFORMANCE, MATERIAL DEFECT, OR SYSTEMIC DESIGN DEFICIENCY WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24411116 ↗
• MalfunctionFeb 23, 2026Fracture

  DURING A STROKE THROMBECTOMY PROCEDURE PERFORMED VIA FEMORAL ACCESS, THE PHYSICIAN OBSERVED SEPARATION AT THE HUB-HYPOTUBE INTERFACE OF A ZEBRA CATHETER WHILE PREPARING TO PERFORM A THIRD PASS WITH A STENT RETRIEVER. THE THIRD PASS WAS NOT PERFORMED. THE STENT RETRIEVER AND ZEBRA CATHETER WERE REMOVED TOGETHER TO PREVENT FURTHER SEPARATION OR POTENTIAL FRACTURE PROGRESSION. NO PATIENT INJURY, PROLONGED PROCEDURE, OR ADDITIONAL MEDICAL INTERVENTION WAS REPORTED. THE PHYSICIAN CONFIRMED THE PATIENT OUTCOME WAS STABLE. EVALUATION OF THE RETURNED DEVICE CONFIRMED A FRACTURE AT THE DISTAL EDGE OF THE STRAIN RELIEF AT THE HUB-HYPOTUBE INTERFACE. THE DAMAGE WAS LOCALIZED TO THE HUB REGION. MICROSCOPIC AND VISUAL INSPECTION OF THE DAMAGED REGION IDENTIFIED NO ABNORMAL COIL SPACING OR PITCH VARIATION, AND THE DISTAL TIP SHOWED NO ABNORMALITIES. THE OBSERVED DEFORMATION MORPHOLOGY IS CONSISTENT WITH MECHANICAL OVERSTRESS INVOLVING COMBINED BENDING AND TORSIONAL LOADING AT THE HUB-HYPOTUBE INTERFACE. DESPITE THE VISIBLE FRACTURE, THE CENTRAL LUMEN WAS ABLE TO BE FLUSHED WHEN THE FRACTURED REGION WAS TEMPORARILY COVERED, AND NO ADDITIONAL BREACHES WERE IDENTIFIED ALONG THE SHAFT. NO EVIDENCE O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24411081 ↗

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